The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block

NCT ID: NCT02451813

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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Recent evidence suggests that injection pressure monitoring may be able to predict needle nerve contact in the brachial plexus nerve block model, but little is known about multifascicular nerves. The investigators hypothesize that injection pressure monitoring can reliably predict needle-nerve contact during femoral nerve block.

Detailed Description

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Single center, observational study. Patients scheduled for elective lower limb surgery with femoral nerve block will be recruited. Femoral nerve will be identified using a linear ultrasound transducer. A 22 GA 5 cm nerve block needle will be inserted with bevel downward and advanced to the following conditions:

1. Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve
2. Needle tip advanced through fascia iliaca
3. Needle tip slightly indenting the anterior surface of the femoral nerve
4. Needle tip withdrawn 1 mm from nerve.

At each of these conditions, 1 ml of dextrose solution will be injected via an automated pump at 10 ml/min and the spread of injectate observed sonographically. Simultaneously, a blinded observer will measure opening injection pressure using both an electronic and a mechanical transducer. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. Patients will be contacted at 7 days and asked about any adverse effects.

Conditions

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Orthopedic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Intervention

A 22 GA 5 cm nerve block needle will be advanced to the following conditions:

1. Needle tip slightly indenting the fascia iliaca
2. Needle tip advanced through fascia iliaca
3. Needle tip slightly indenting the anterior surface of the femoral nerve
4. Needle tip withdrawn 1 mm from nerve.

At each of these conditions, 1 ml of dextrose solution will be injected and spread of injectate observed sonographically. A blinded observer will measure injection pressure. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4.

Group Type EXPERIMENTAL

Apposition of needle bevel against femoral nerve

Intervention Type PROCEDURE

Indentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution

Interventions

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Apposition of needle bevel against femoral nerve

Indentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-65
* ASA physical status I-III
* scheduled for lower limb surgery where femoral block is part of intended analgesic plan

Exclusion Criteria

* Contraindication to femoral nerve block (e.g. infection)
* BMI \> 35 kg/m2
* inability to communicate postoperative symptoms
* pre-existing neurologic deficits in the operative extremity
* allergy to local anesthetics
* history of opioid dependence
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malikah Latmore, MD

Role: STUDY_DIRECTOR

Mount Sinai St. Luke's Mount Sinai Roosevelt Hospitals

Locations

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St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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StLukeNY

Identifier Type: -

Identifier Source: org_study_id

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